ABSTRACT
Introduction and Historical Background of US Pharmacopeia .............................. 320 USP Overview: Content and Processes ................................................................. 321
Scope of the Publications: USP and NF ............................................................ 321 USP Governance, Standards-Setting, and Advisory Bodies ............................. 322
USP Convention ........................................................................................... 322 USP Board of Trustees ................................................................................. 322 USP Council of Experts ............................................................................... 322 Expert Panels to the Council of Experts ....................................................... 323 Stakeholder Forums and Project Teams ....................................................... 323
USP’s Role in Established Drug Names ........................................................... 323 Content of USP-NF .......................................................................................... 323
USP-NF Organization and Revision Process ............................................... 325 Revisions to USP-NF ................................................................................... 326 Pharmacopeial Forum ................................................................................... 327 Supplements ................................................................................................. 327 USP Reference Standards ............................................................................. 327 Commentary ................................................................................................. 327 Public Participation ...................................................................................... 328 Working with the FDA ................................................................................. 329
USP and Generic Products ..................................................................................... 329 Pharmacopeias Worldwide ..................................................................................... 330 Pharmacopeial Harmonization ............................................................................... 330 References .............................................................................................................. 331
Today’s global pharmaceutical industry arose from individual practitioners compounding their own medications. In 1820, a group of American physicians concerned with the quality and consistency of medicines created the U.S. Pharmacopeia (USP), essentially a book of recipes for commonly used medicinal preparations (Figure 14.1) [1]. Over time, the USP Convention evolved, both as a publication and as an organization, in parallel with the emerging pharmaceutical industry that largely took the place of individual compounders. In a 1950 edition of the Bulletin of the World Health Organization, Dr. George Urdang published an influential paper on “The Development of Pharmacopeias” [2]. Dr. Urdang was a distinguished professor of pharmacy at the University of Wisconsin and also was a driving force in the development of the USP into a modern, global public health organization. Dr. Urdang defined a pharmacopeia as “a compilation intended to secure uniformity in medicinal agents as to kind, quality, composition, and therapeutic strength, whose specifications are legally obligatory within a defined political area” [3]. For nearly a century, USP’s drug standards have met that definition in the United States, and USP standards also are in used in more than 145 countries.
